Date published: March 1, 2010
The U.S. Food and Drug Administration (FDA) unveiled an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography. CT, nuclear medicine, and fluoroscopic imaging have led to early diagnosis of disease, improved treatment planning, and image-guided therapies that help save lives every day.
However, like all medical procedures, CT, nuclear medicine, and fluoroscopy pose risks. These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person's lifetime cancer risk. Accidental exposure to very high amounts of radiation also can cause injuries, such as skin bums, hair loss and cataracts. Healthcare decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure. While there is some disagreement over the extent of the cancer risk associated with exposure to radiation from medical imaging, there is broad agreement that steps can and should be taken to reduce unnecessary radiation exposure.
Through the FDA's regulatory oversight of medical imaging devices, such as CT scanners, and through collaboration with other federal agencies and healthcare professional groups, the FDA is advocating the adoption of two principles of radiation protection: appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure. The three-pronged initiative the FDA is announcing will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure.
The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting Mardi 3031, 2010, to solicit input on what requirements to establish.
Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level , training for users, and a requirement mat devices be able to capture and transmit radiation dose information to a patient's electronic medical record and to national dose registries.
In addition, the FDA and the CMS are collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals.